Sterile cleaning kit

ABSTRACT

A kit for forming a sterile cleaning solution. The kit is comprised of a container, a packet, a first flexible package and a second flexible package. The container contains a liquid and has an opening and a removable cap sealing the opening. The packet contains a pre-measured amount of an active agent. The first flexible package is dimensioned to enclose the container and the packet. The second flexible package is dimensioned to enclose the first flexible package, the container and the packet.

FIELD OF THE INVENTION

The present invention relates generally to cleaning solutions, and moreparticularly, to a self-contained kit for the preparation of a sterilecleaning and/or disinfectant solution.

BACKGROUND OF THE INVENTION

Clean-rooms, operating rooms, and the like must be periodically cleanedand disinfected with sterile solution to maintain clean and sterileconditions therein. The sterile solution is typically formed by mixingsterile water and a sterile disinfecting or sterilant agent. Immediatelyprior to use, the sterile solution may be mixed in the room in which thesolution is to be used. Conventional methods for forming a sterilecleaning solution involve measuring and pouring predetermined amounts ofa disinfecting agent and water into a container such as a bucket.

A problem associated with such mixing procedures is the potentialexposure of a user to harsh and toxic chemicals. Another problem ismeasuring the respective components accurately to obtain a propercleaning solution. Measuring of the respective components improperly mayreduce the effectiveness of the final sterile cleaning solution, orresult in increased costs due to overuse of expensive materials. Anotherproblem associated with the current practice is the need to closelycontrol and document the mixing activity which adds time and labor tothe process.

The present invention overcomes these and other problems and provides asterile cleaning kit containing a pre-measured volume of sterile wateror liquid and a pre-measured, sterile packet of disinfectant orsterilant attached thereto.

SUMMARY OF THE INVENTION

In accordance with the present invention, there is provided a kit forforming a sterile cleaning solution. The kit is comprised of a containercontaining a sterile water or liquid. The container also has an openingand a removable cap that seals the opening. A sterile packet or othercontainer containing a pre-measured amount of an active agent such asdisinfectant or sterilant, is attached to the container. The containerand attached packet or other container are enclosed within a sealedflexible inner bag or package. The inner bag or package is furtherenclosed within a sealed flexible outer bag or package and the entiresystem is then sterile.

In accordance with another aspect of the invention, there is provided asterile cleaning solution kit as described above, having a packet thatis configured such that a portion of the packet defines a pour spout orfinger portion. The pour spout or finger portion is dimensioned to fitwithin an opening in the container to allow for safe, efficient transferof the disinfecting or sterilizing agent to the container or anadditional mixing bucket, without exposure to the operator or loss ofproduct during transfer.

In accordance with another aspect of the present invention, there isprovided a kit for forming a sterile cleaning solution comprising afirst container containing a liquid carrier fluid. The container has anopening and a removable cap. A second container contains an active agentoperable to form a cleaning solution when mixed with the liquid carrier.At least one flexible package is provided to enclose the first andsecond containers to maintain the container in a sterile condition.

An advantage of the present invention is a self-contained sterile kitfor forming a sterile cleaning and/or disinfectant solution.

Another advantage of the present invention is a kit as defined abovehaving a packet or other container that is dimensioned to provide safe,efficient transfer of the disinfectant or sterilizing agent into theoriginal container for the sterile water or an additional mixing bucket.

Another advantage of the present invention is a kit as defined abovethat provides pre-measured amounts of sterile water or liquid, and thedisinfecting or sterilizing agent, and the pre-measured componentsallowing for accurate formation of the sterile cleaning solution.

Another advantage of the present invention is a kit as defined abovethat reduces waste and associated costs from improper mixing ofcomponents.

Another advantage of the present invention is a kit as defined abovethat facilitates the effectiveness of the cleaning solution.

Another advantage of the present invention is that a user does not needto provide sterile water or liquid in areas which are consideredcritical, thus providing a substantial savings and convenience for theuser.

Another advantage of the present invention is that a user does not needto provide filtration for the components or the finished blendeddisinfectant/sterilant solution, again providing a considerable savingsand convenience for the user.

These and other advantages will become apparent from the followingdescription of a preferred embodiment taken together with theaccompanying drawings and the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention may take physical form in certain parts and arrangement ofparts, a preferred embodiment of which will be described in detail inthe specification and illustrated in the accompanying drawings whichform a part hereof, and wherein:

FIG. 1 is an elevational view of a kit for forming a sterile cleaningsolution illustrating a preferred embodiment of the present invention;

FIG. 2 is a partial sectional view taken along line 2-2 of FIG. 1; and

FIG. 3 is a partially sectioned view of the kit for forming a sterilecleaning solution shown in FIG. 1, illustrating use of the kit forforming a sterile cleaning solution.

DETAILED DESCRIPTION OF A PREFERRED EMBODIMENT

Referring now to the drawings wherein the showings are for the purposesof illustrating a preferred embodiment of the present invention only andnot for the purposes of limiting same, FIG. 1 shows a sterile solutionkit 10 for creating (forming) a sterile cleaning solution. Broadlystated, sterile solution kit 10 is comprised of a container 20, a packet40, an inner bag 60 and an outer bag 70.

In the embodiment shown, container 20 is generally cylindrical orrectangular in shape and has a closed bottom end 21 and an open upperend 23. Upper end 23 of container 20 is formed to define a throat 32 anda handle 34. Container 20 is a rigid or soft-sided container whereinthroat 32 and handle 34 are integrally formed. Bottom end 21 ofcontainer 20 defines a support surface 36. Support surface 36 is formedto allow container 20 to be free standing on a flat surface. An optionmay be to package a soft sided container that has other featuresdesigned to make it stable on a flat surface. Handle 34 is dimensionedto allow lifting, carrying, positioning, and pouring of container 20.

Referring now to FIG. 2, upper end 23 of container 20 narrows to formthroat 32. Throat 32 has exterior threads 28 as shown in FIG. 2 anddefines an opening 26. In the embodiment shown, opening 26 is round.Opening 26 is sealed by cap 24. Cap 24 includes internal threads 25dimensioned to matingly engage exterior threads 28 on container 20.

Container 20 is dimensioned to contain a predetermined amount of asterile inactive liquid 22. In a preferred embodiment of the invention,sterile inactive liquid 22 is water, and in a more preferred embodimentof the invention, sterile inactive liquid 22 is sterile water and in aneven more preferred embodiment of the invention, sterile inactive liquid22 is a sterile grade of water that meets the specification of USP waterfor injection (WFI water).

Packet 40 is best seen in FIG. 1. In a preferred embodiment, packet 40is generally rectangular in shape and includes an elongated fingerportion 50 that extends from one corner thereof. Packet 40 is formed oftwo layers of flexible metallic foil that are heat sealed around theperimeter thereof to form a packet flange 44. Packet 40 defines an innerchamber 46 that is dimensioned to receive a pre-measured amount of anactive agent 48, such as a disinfectant or sterilant. Another possibleconfiguration for packet 40, i.e., the container of the disinfectant orsterilant, would be a rigid or soft sided bottle that is shaped to beeither separate or attached to the base bottle or container.

In a preferred embodiment, finger portion 50 is an extension of a longside of packet 40, but it is recognized that finger portion 50 couldextend from any portion of packet 40 and finger portion 50 could befolded parallel to the body of packet 40. Finger portion 50 has a mesialportion 53, and a distal end 54. Finger portion 50 defines an innerpassageway 51. Inner passageway 51 is fluidly connected to inner chamber46. Finger portion 50 is configured to tear or otherwise be opened sothat distal end 54 is separated from mesial portion 53 along a tear line55, shown as a dashed line in FIG. 1. In a preferred embodiment, surfacemeans such as a notch 56 is formed in packet flange 44 to facilitateremoval of distal end 54 from mesial portion 53 along tear line 55, aswill be discussed below.

Referring now to FIG. 3, finger portion 50 is dimensioned to fit throughopening 26 and within throat 32 of container 20. Finger portion 50 isdimensioned to provide means for efficient transfer of liquid throughopening 26 and throat 32 and into container 20.

In a preferred embodiment, packet 40 is attached to container 20 by anadhesive at locations 42A and 42B as best seen in FIG. 2. The adhesiveis preferably a hot-melt adhesive. In the embodiment shown the adhesiveis configured in two, parallel spaced-apart lines. It is contemplatedthat the adhesive could be configured in a single patch, a line definingthe perimeter of packet 40, a series of dots across the back of packet40 or some other known means of attaching. It is also contemplated thatpacket 40 may be attached to container 20 by other means, such as, byway of example and not limitation, adhesive tape across the exterior ofpacket 40 and the surface of container 20, a surrounding label band, andadhesive in any configuration or equivalents.

Inner bag 60 is a flexible package that is dimensioned to receivecontainer 20 and packet 40. In a preferred embodiment, inner bag 60 ismade of a clear polymeric material which is heat sealed around theperimeter to form inner bag flange 62 as shown in FIG. 1. Inner bag 60may be comprised of a single or multilayered barrier material comprisedfrom a polymer or other application specific materials.

Inner bag 60 is comprised of a material that has properties appropriateto sterile containment. Such properties would be low permeability tomicroorganism transfer, resistant to handling/transit damage andsterilization process stability. Inner bag 60 has a thickness that iseasy to tear, cut, or peel open. In a preferred embodiment, inner bagflange 62 of inner bag 60 is formed such that it can be peeled open atinner bag top 64 of inner bag 60. Alternatively, inner bag 60 may beformed of a polymeric material oriented to facilitate tearing oropening.

Outer bag 70 is a sealed flexible package that is dimensioned to belarger than inner bag 60 and is dimensioned to receive inner bag 60,container 20, and packet 40. Outer bag 70 is preferably formed of thesame material as inner bag 60 to have the same characteristics andproperties as inner bag 60 as discussed above. In a preferredembodiment, outer bag 70 is made of a clear polymeric material which isheat sealed around the perimeter to form outer bag flange 72 as shown inFIG. 1. Outer bag 70 may be comprised of a single or multilayeredbarrier material comprised from a polymer or other application specificmaterials. Outer bag 70 is comprised of a material that has propertiesappropriate to sterile containment. Such properties would be lowpermeability to microorganism transfer, resistant to handling/transitdamage and sterilization process stability. Outer bag 70 has a thicknessthat is easy to tear, cut, or peel open. In a preferred embodiment,outer bag flange 72 of outer bag 70 is formed such that it can be peeledopen at outer bag top 74 of outer bag top 70. Alternatively, outer bag70 may be formed of a polymeric material oriented to facilitate tearingor opening. When open, outer bag top 74 would allow the removal of innerbag 60.

The complete sterile solution kit 10 comprised of container 20, attachedpacket 40, inner bag 60, and outer bag 70 is irradiated with gammaradiation for sterility. In an alternative embodiment, the individualcomponents of sterile solution kit 10 could be sterilized separately andthen assembled in a sterile environment.

Referring now to the operation and use of sterile solution kit 10, it isrecognized that procedures vary from facility to facility and thatsterile solution kit 10 would be used in accordance with the proceduresin effect at the facility to be cleaned. The method of use of sterilesolution kit 10 begins with observing relevant entry procedures for theenvironment to be cleaned.

In a preferred method of use, outer bag 70 is opened in a locationoutside or away from the area to be cleaned. Outer bag 70 is opened atouter bag top 74 by separating outer bag flange 72. After outer bag 70is opened, inner bag 60 is removed from outer bag 70. Following theremoval of inner bag 60 from outer bag 70, outer bag 70 is discarded.Once outer bag 70 is removed and discarded, the remainder of sterilesolution kit 10 comprising container 20, attached packet 40, and innerbag 60 is transferred to the area to be cleaned. Inner bag 60 is openedat inner bag flange 62 or by some other suitable method. Container 20and attached packet 40 are removed from inner bag 60. Packet 40 is thendetached from container 20. Cap 24 is removed from container 20 therebyexposing opening 26. Cap 24 is retained for future use.

Grasping packet 40 at mesial portion 53 and distal end 54, distal end 54is separated from packet 40 along tear line 55. Once separated frompacket 40, distal end 54 is disposed of. Distal end 54 may be placedwithin inner bag 60 for disposal.

Removal of distal end 54 defines an opening 58, best seen in FIG. 3.

Packet 40 is then maneuvered so that mesial portion 53 is placed inopening 26 within throat 32, and the active agent 48 within packet 40 ispoured into container 20. Packet 40 is then disposed of within inner bag60. Inner bag 60 is then sealed and disposed of appropriately. Cap 24 isplaced over opening 26 and tightened on exterior threads 28 so thatcontainer 20 is sealed. Formation of the sterile cleaning solution maythen be completed by appropriate agitation or mixing. Cap 24 can then beremoved and the resulting solution of sterile inactive liquid 22 andactive agent 48 can be used as needed. Alternatively, the user may emptypacket 40 and container 20 into a larger container or bucket to be mixedand used with an application device such as a mop.

The present invention thus provides a pre-measured kit for the formationof a cleaning solution to be used in clean rooms, operating rooms, andthe like.

Modifications and alterations will occur to others upon their readingand understanding of the specification.

For example, container 20 may assume other shapes, and the opening 26 incontainer 20 may be sealed by other means such as a peel-away metallicfoil or polymer cap. Further, packet 40 could also made of othermaterials such as, by way of example and not limitation, a polymericfilm, a laminate structure comprised of metallic foil and polymericfilm, or a polymeric film coated with metal. Likewise, packet 40 can berigid or semi-flexible. It is intended that all such modifications andalterations be included insofar as they come within the scope of theinvention as claimed or the equivalents thereof.

1. A kit for forming a sterile cleaning solution, comprising: acontainer containing a liquid, said container having an opening and aremovable cap sealing said opening; a packet containing a pre-measuredamount of an active agent; a first flexible package dimensioned toenclose said container and said packet; and a second flexible packagedimensioned to enclose said first flexible package, said container andsaid packet.
 2. The kit as defined in claim 1, wherein said packet isattached to, yet removable from, the exterior of said container.
 3. Thekit as defined in claim 2, wherein said packet is attached to saidcontainer by an adhesive.
 4. The kit as defined in claim 1, wherein saidpacket has a finger portion and said packet is openable at said fingerportion.
 5. The kit as defined in claim 4, wherein said finger portionhas a surface feature dimensioned to facilitate opening.
 6. The kit asdefined in claim 5, wherein said finger portion has a flange and saidsurface feature is a notch in said flange.
 7. The kit as defined inclaim 1, wherein said opening is dimensioned to receive said fingerportion.
 8. The kit as defined in claim 4, wherein said finger portionis dimensioned to fit within said opening.
 9. The kit as defined inclaim 1, wherein said liquid is water.
 10. The kit as defined in claim9, wherein said liquid is sterile water.
 11. The kit as defined in claim10, wherein said liquid is a sterile grade of water that meets thespecification of USP water for injection.
 12. The kit as defined inclaim 1, wherein said active agent is a disinfectant.
 13. The kit asdefined in claim 1, wherein said active agent is a sterilant.
 14. Thekit as defined in claim 1, wherein said active agent is a cleaner. 15.The kit as defined in claim 1, wherein said container is comprised of apolymer.
 16. The kit as defined in claim 1, wherein said first flexiblepackage is comprised of a first polymer.
 17. The kit as defined in claim16, wherein said first polymer is clear.
 18. The kit as defined in claim16, wherein said flexible package is comprised of single ormulti-layered barrier material comprised from a polymer.
 19. The kit asdefined in claim 1, wherein said second flexible package is comprised ofa second polymer.
 20. The kit as defined in claim 19, wherein saidsecond polymer is clear.
 21. The kit as defined in claim 19, whereinsaid second flexible package is comprised of single or multi-layeredbarrier material comprised from a polymer.
 22. A kit for forming asterile cleaning solution, comprising: a first container containing aliquid carrier fluid, said container having an opening and a removablecap; a second container containing an active agent operable to form acleaning solution when mixed with said liquid carrier; and at least oneflexible package dimensioned to enclose said first and second containersand maintain said container in a sterile condition.
 23. A kit as definedin claim 22, wherein said second container is a packet.
 24. A kit asdefined in claim 23, wherein said packet is attached to said firstcontainer.
 25. A kit as defined in claim 24, wherein said kit includes asecond flexible package dimensioned to enclose said at least oneflexible package.
 26. A kit as defined in claim 25, wherein said activeagent is a liquid disfinfectant.
 27. A kit as defined in claim 25,wherein said active agent is a liquid sterilant.
 28. A kit as defined inclaim 25, wherein said flexible packages are formed of a polymermaterial.